BYU accuses Pfizer of bilking
After discovering a new enzyme in 1989, Brigham Young University professor Daniel L. Simmons realized his find might lead to a painkiller that would reduce inflammation without the stomach problems caused by existing drugs.
But rather than patent the discovery, the private school placed its trust in a powerful drugmaker and, according to a new lawsuit, was cheated out of billions of dollars as a result.
The lawsuit, filed Wednesday in U.S. District Court in Salt Lake City, says Simmons' research was crucial to the development of the blockbuster anti-inflammatory drug Celebrex, created by a predecessor company of Pfizer. The suit claims the pharmaceutical company has violated an unpublicized 1991 deal by cheating the school out of profits and credit for the development of the medication, with sales estimated at more than $20 billion.
Simmons and the Provo university seek actual and punitive damages, now estimated to be "significantly in excess of $1 billion."
They also want corrections to 75 patents, in order to credit Simmons for his work.
Simmons claims to have discovered that an enzyme known as cyclooxygenase was actually two enzymes, with his purported find since dubbed COX-2. That led to the class of drugs known as COX-2 inhibitors, the lawsuit contends.
These drugs selectively block COX-2, enzymes produced by the body when inflammation occurs, without inhibiting COX-1. Blocking COX-1 can cause stomach bleeding.
BYU said the lawsuit was filed after years of behind-the-scenes negotiations to capture profits from Celebrex failed.
Pfizer spokesman Bryant Haskins called the lawsuit's allegations baseless and said Simmons played no role in the discovery of Celebrex.
"The facts simply don't support the unfounded claims made in this lawsuit and Pfizer will of course mount a vigorous defense," Haskins said. "We did have a research agreement with BYU and we're confident the facts will clearly show Monsanto (a predecessor company of Pfizer) met all the obligations of the agreement."
The lawsuit contends Monsanto and its successor companies "were heading down another research path that would never have led to the development of a COX-2 selective NSAID such as Celebrex," before joining with Simmons, a biochemistry professor.
BYU asserts it had a 1991 contract with Monsanto to collaborate on development of an aspirinlike drug, called a nonsteroidal anti-inflammatory drug (NSAID). Monsanto was required to alert the university if results from the project could be patented, and to share profits, according to the lawsuit.
But Monsanto misappropriated the project, the suit claims.
In early 1992, the company used Simmons' confidential information to test a compound patented by another scientist, to see if it could be developed into a COX-2 selective drug, the suit alleges.
In March 1992, Monsanto's chief scientific officer, Philip Needleman, ended the deal with BYU, complaining Simmons was not communicating about his research, the suit said. Then, Monsanto launched a public relations campaign to convince the world that Needleman had discovered COX-2, it said.
The suit charges Monsanto's reasons for terminating the agreement with BYU was a pretext. It asserts the professor's telephone logs show more than 60 calls to Monsanto during the time the deal was in place, and many calls from the company to Simmons and his colleagues.
Celebrex was approved for clinical use by the U.S. Food and Drug Administration on Dec. 31, 1998, and went on sale in January 1999. Four months later, competitor Merck began selling its own COX-2 selective NSAID, Vioxx.
That prompted Monsanto, by then named G.D. Searle & Company, to sue Merck for alleged patent infringement. Merck, in turn, asked Simmons to testify as an expert witness.
While preparing his testimony, Simmons was stunned to realize Monsanto had used his own materials to develop Celebrex, the lawsuit claims.
The suit contends the original agreement with Monsanto remains in force because the company's termination was fraudulent.
"Monsanto took Dr. Simmons' findings and technologies and went on to develop Celebrex without him, which we believe violated the terms of the contract by sharing none of the credit or compensation," said BYU spokesman Michael Smart.
BYU publicized Simmons' discovery at the time, but not the contract with Monsanto and its successors until now, Smart said.
He said the school has been trying to settle the dispute out of court for years. In January, the two sides hired a professional mediator but still couldn't resolve the dispute. BYU turned to legal action as a last resort, Smart added.
In a statement released through BYU, Simmons said he is looking forward to resolving the issue.
"I appreciate the support of the university and I am grateful that the real story behind this research will come out," he said. "I'm also grateful for the encouragement and support of many friends in the scientific community through the years."
At a glance:
* What BYU says: Pfizer stole groundbreaking discoveries by a BYU professor and used them to develop the blockbuster pain reliever Celebrex.
* What Pfizer says: The lawsuit is baseless.
* What's at stake: Billions of dollars in profits for BYU and recognition for professor Daniel Simmons' research.
* Why now: Parties tried for seven years to reach an agreement but failed.
How BYU wound up filing suit:
Here is a timeline of claims outlined in BYU's lawsuit against Pfizer. The drugmaker, while not addressing individual allegations, says the lawsuit is baseless.
Daniel L. Simmons is hired by BYU and begins work with Weilin Xie, a graduate student. Simmons discovers a new enzyme, known as COX-2, that could be useful in developing a pain and inflammation blocker.
Barry Haymore, a Monsanto scientist, visits BYU and learns of Simmons' discovery. Simmons presents his findings at Monsanto, provides a written proposal for collaboration and asks about patent rights. Monsanto tells him not to patent his discoveries, saying the patents would be unenforceable.
Simmons publishes his discovery of COX-2 in the Proceedings of the National Academy of Sciences. He withholds certain proprietary information for use in a deal with an industrial partner.
BY JULY 1991
Monsanto and BYU sign a collaborative agreement. Simmons is sending the company his trade secrets. The contract says Simmons would direct the project, Monsanto would notify Simmons and BYU of any patentable results, and the two would share profits.
Monsanto starts a separate, secret project on COX enzymes but does not notify BYU. In March, Monsanto and BYU terminate their agreement after the company sends Simmons a letter saying the school has not lived up to its end of the deal and the situation is "unworkable."
In patents, news releases and statements to investors and the FDA, Monsanto claims its own research led to the discovery of COX-2 and Celebrex, a pain-relieving drug that inhibits production of the enzyme.
Drugmaker Merck asks Simmons to testify in Monsanto's patent infringement litigation against Merck, maker of its own COX-2 drug, Vioxx. Simmons learns Monsanto used his research to develop Celebrex.
The FDA approves Celebrex for clinical use. The drug goes on sale in January 1999.
Attorneys for BYU and Monsanto - which has since merged with Pfizer - spend the next seven years dickering over the contract and its validity.
OCT. 18, 2006
BYU sues Pfizer for breach of contract, saying Simmons and the school were cheated out of credit and profits.